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Experimental: Tryptophan in healthy young adults (18-45 years) for Healthy Subjects

N/A
Waitlist Available
Led By Glenda Courtney-Martin, PhD, RD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Consent provided
2. Aged 18 to 45 years old (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 hours
Awards & highlights

Summary

Tryptophan is an essential amino acid needed for growth and bodily functions. It is used to make serotonin which is needed for the brain to develop and function properly. However, when the body is stressed, tryptophan is broken down into compounds that can cause harm to the brain. Premature babies who get nutrition through their vein \[i.e. total parenteral nutrition (TPN)\] can experience this type of stress. The amount of tryptophan in TPN solutions is much higher than what premature babies need and can produce too much harmful compounds. So, it is important to study the amount of these compounds made from tryptophan. But there are no methods available to study this. Therefore, the goal of this study is to develop a method to measure the compounds made from tryptophan breakdown in adults so that it can be used for preterm babies on TPN later.

Who is the study for?
This trial is for healthy young adults. Specific eligibility criteria are not provided, but typically participants should have no significant health issues that could interfere with the study.
What is being tested?
The study aims to develop a method to measure compounds resulting from tryptophan breakdown. This will help understand its metabolism in stressed conditions like those experienced by premature babies on TPN.
What are the potential side effects?
Since this trial involves monitoring tryptophan intake in healthy individuals, side effects are expected to be minimal or related to potential dietary changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fractional Synthesis Rate (FSR) of tryptophan metabolites
Steady state
Secondary study objectives
Fractional synthesis rate (FSR)
Partitioning of tryptophan metabolism

Side effects data

From 2019 Phase 2 & 3 trial • 93 Patients • NCT02067975
19%
Nausea
11%
Vomiting
6%
Dizziness
6%
Sedation
3%
Syncope
3%
Headache
3%
Drowsniess
3%
Abdominal Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Control: Tryptophan
Schizophrenia Related Disorders: Tryptophan
Healthy Controls: Placebo
Schizophrenia Related Disorders: Screening
Schizophrenia Related Disorders: Placebo
Healthy Controls: Screening

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: Tryptophan in healthy young adults (18-45 years)Experimental Treatment1 Intervention
Tryptophan intake levels, up to 5 levels, will be tested in a random order in all subjects

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
699 Previous Clinical Trials
6,953,149 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,362 Previous Clinical Trials
26,507,037 Total Patients Enrolled
Glenda Courtney-Martin, PhD, RDPrincipal InvestigatorThe Hospital for Sick Children
5 Previous Clinical Trials
192 Total Patients Enrolled
~4 spots leftby Dec 2024